Simvastatin as an Augmentation Treatment for Treatment Resistant Depression: Randomized Controlled Trial.

Phase 3

Completed

• Conditions: Treatment Resistant Depression; Major Depressive Disorder
• Interventions: Drug: Simvastatin 20 mg; Other: Placebo Oral Tablet

• Registration Number: NCT03435744
• Lead Sponsor: Pakistan Institute of Living and Learning

Brief Summary

In this double blind, randomized placebo controlled trial we aim to determine the efficacy of simvastatin as an add-on treatment for treatment resistant depression. We will recruit 150 people with treatment-resistant depression with the aim of determining whether the addition of simvastatin (20mg daily) to treatment as usual (TAU) for 12 weeks leads to an improvement in depressive symptom compared with placebo added to TAU.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-19
• Study Start: 2019-01-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• DSM-5 current major depressive episode
• Must currently be on an antidepressant and must have had a non-response to >2 oral antidepressant treatments in the current episode (including the one they are currently taking).
• Capacity to give informed consent
• Willing to use adequate contraception
• Give written informed consent

Exclusion Criteria

• Primary psychotic or bipolar disorder
• History of intolerance to statins or presence of any contraindication to statins
• Presence of any serious medical condition or neurological problem
• Presence of autoimmune or inflammatory disorder
• Alcohol or drug dependence
• Active suicidal ideation
• Pregnant or breast-feeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simvastatin with TAU	Simvastatin 20 mg	Participants will receive Simvastatin 20 mg added to TAU for 3 months
Placebo Oral Tablet with TAU	Placebo Oral Tablet	Participants will receive placebo added to TAU for 3 months

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery Asberg, 1979)	Week-2, Week-4, Week-8 and Week-12	The MADRS will be used as primary outcome measure in estimating depression severity

Trial Locations

Locations (3)

Civil Hospital; 🇵🇰 Karachi, Pakistan

Abbasi Shaheed Hospital; 🇵🇰 Karachi, Pakistan

Institute of Professional Psychology; 🇵🇰 Rawalpindi, Pakistan